NeuAge Institute (NAI)

3 Things to Consider when Conducting Safety Monitoring in Clinical Trials after Pharmacovigilance Courses

Clinical trial monitoring is integral to the safety and effectiveness of trials and is a key component of Good Clinical Practice (GCP). Why? Safety monitoring ensures that the treatment or procedure remains consistent and risk-averse for each and every trial participant, allows for the production of accurate data and research and facilitates the completion of each trial phase within the necessary time frames. Monitoring activities can take many different shapes and forms, depending on the metrics, objectives, risks, and environment that define a particular clinical trial. 

If you’re interested in a career in pharmacovigilance, it’s likely that you’ll be working to carry out monitoring processes within clinical trials. After completing your training at the NeuAge Institute, you’ll be prepared to ensure the safety and efficacy of the trials you work on. Below are three things to consider.

1. Conduct Risk Assessment After Pharmacovigilance Courses

Often, the first step when it comes to safety monitoring a clinical trial is conducting risk assessment. Risk assessment procedures allow for the delegation of roles in the monitoring process, determining areas of risk and identifying where more personnel will be needed to ensure oversight. There are many different factors to consider in conducting a risk assessment. After your pharmacovigilance and drug safety training, be sure to determine:

 

  • Disease area: duration of illness
  • Design of the trial: complex or simple, randomized
  • Number and location of trial sites
  • Data management systems used
  • Vulnerability of study population
  • Investigational Medicinal Product
  • How oversight is conducted

Diving deeper into these areas will make it easier to determine how much monitoring is required for a trial to be effective and safe.

pharmacovigilance courses
After pharmacovigilance courses, conduct a risk assessment to strategize the monitoring process

2. Consider What Type of Monitoring to Implement

Different types of monitoring exist to suit the unique needs of different clinical trials, and monitoring types may be combined to meet a trial’s needs. A few examples are:

 

  • Central monitoring: Trial data is uploaded and reviewed by a central coordinating body, which also uses trial reports to ensure efficacy.
  • On-site monitoring: Regular visits to the site of the trial by a designated monitor, with reports being produced at each visit.
  • Central-statistical monitoring: With the development of statistical algorithms, missing data or unusual patterns can be identified, helping to refocus monitoring efforts.
  • Risk-adapted monitoring: With more complex trials, this approach has become more popular, setting priorities for monitoring based on risk level to create a less resource-intensive and more focused monitoring process.
  • Trial committees for oversight: Trial is overseen by different supervision committees, such as a Data Monitoring Committee or a Trial Steering Committee, typically in the case of trials involving vulnerable populations.

Depending on the complexity of the trial and the nature of the study population and data, one or more types of monitoring may be chosen.

pharmacovigilance and drug safety training
The monitoring type chosen reflects the unique needs of the clinical trial

3. Create a Monitoring Plan

After the risk assessment has been conducted and the right type(s) of monitoring determined, a monitoring plan can be developed. During pharmacovigilance courses, you’ll learn how to create a monitoring plan that suits the unique parameters of a specific clinical trial. A monitoring plan includes all monitoring activities, as well as oversight by committees and oversight of the supplies and vendors utilized in a particular trial. A monitoring plan will account for the monitoring of informed consent, data verification, pharmacy monitoring, laboratory monitoring, monitoring for adverse events, and more, implementing a plan for navigating each of these different areas. With training at the NeuAge Institute, you’ll be prepared to successfully create a monitoring plan that enhances a trial’s safety and efficacy after gathering the necessary information.

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